Validation Engineer

Job Description:

Job Title : Validation Engineer,

Job Location : Lincoln, RI,

Job Type : Full-time role

Salary : 110K/Annum

Validation Engineer

Seeking a capable Validation Engineer to work in the RI area. Ideal candidates would have previous experience supporting validation activities within a fast-paced pharmaceutical environment. This includes installation, operational and performance qualification of equipment and utilities, environmental qualification, and preparation of all relevant documentation to meet regulatory requirements (including standard operating procedures, technical reports, and risk assessments).

Validation Engineer Key Responsibilities:

The candidates responsibilities will include, but are not limited to:

Develop protocols, and provides execution support, data analysis, and report generation for various installation, operational, and performance qualification activities.

Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry, and regulatory guidance.

Ensure all aspects of facilities validation adhere to required policies and procedures, including safety and training.

Investigates / troubleshoots validation problems.

Support and/or initiate investigations into protocol non-conformances and site deviations.

Serve as initiator and owner of validation-related change controls and corrective and preventative actions.

Provides input to standard operating procedures related to validation practices.

Support the implementation of validation programs (e.g., requalification).

Executing thermal mapping of the facility.

Validation Engineer Qualifications & Experience:

Bachelors degree in Engineering or Science or related field.

2+ years of experience within the biotech or pharmaceutical industry

Must have demonstrated understanding of cGMP.

Strong problem-solving and analytical skills

Understanding of compliance and regulations.

Excellent written and verbal communication skills.

Remote Work :

No